{"id":6897,"date":"2019-02-27T18:21:46","date_gmt":"2019-02-27T17:21:46","guid":{"rendered":"https:\/\/productosanitario.es\/prior-license-to-operate-a-medical-device\/"},"modified":"2025-03-06T15:39:28","modified_gmt":"2025-03-06T14:39:28","slug":"prior-license-to-operate-a-medical-device","status":"publish","type":"page","link":"https:\/\/productosanitario.es\/en\/prior-license-to-operate-a-medical-device\/","title":{"rendered":"Prior license to operate a medical device"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"6897\" class=\"elementor elementor-6897 elementor-2814\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4dbc194 e-con-full e-flex e-con e-parent\" data-id=\"4dbc194\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-855b4a5 e-con-full e-flex e-con e-child\" data-id=\"855b4a5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6ee3354 elementor-widget elementor-widget-heading\" data-id=\"6ee3354\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">Prior license to operate a <b>medical device<\/b><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-739ef73 elementor-widget elementor-widget-text-editor\" data-id=\"739ef73\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In accordance with <a href=\"https:\/\/productosanitario.es\/category\/rd-192-2023-producto-sanitario\/\" target=\"_blank\" rel=\"noopener\">Royal Decree 192\/2023<\/a>, natural or legal persons engaged in the manufacture, manufacture to third parties, import, grouping or sterilisation of <a href=\"https:\/\/www.productosanitario.es\/producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">medical devices<\/a> and the facilities in which such activities are carried out will require <a href=\"https:\/\/www.productosanitario.es\/licencia-previa-de-funcionamiento-de-producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">a prior operating licence<\/a> granted by the <a href=\"https:\/\/www.productosanitario.es\/aemps\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">AEMPS.<\/a><\/p><p>The establishments and activities of natural or legal persons engaged in the manufacture of custom-made products shall require a prior operating licence granted by the health authorities of the corresponding Autonomous Community.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3ca79a4 e-con-full e-flex e-con e-child\" data-id=\"3ca79a4\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-399bc45 e-flex e-con-boxed e-con e-parent\" data-id=\"399bc45\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f4277dc e-con-full e-flex e-con e-child\" data-id=\"f4277dc\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-6ecd094 e-con-full e-flex e-con e-child\" data-id=\"6ecd094\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-4d8aada elementor-widget elementor-widget-text-editor\" data-id=\"4d8aada\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The <a href=\"https:\/\/www.productosanitario.es\/licencia-previa-de-funcionamiento-de-producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">prior operating licence<\/a> will cover both its own and contracted facilities and activities, with special attention to those carried out by <a href=\"https:\/\/productosanitario.es\/el-alcance-y-responsabilidad-del-subcontratista-critico\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">critical subcontractors<\/a>, and may even require an audit of their facilities.<\/p><p>Any modification of the conditions under which the license was granted must be previously authorized by the issuing body.<\/p><p>Application requirements:<\/p><ul><li>Have an organizational structure capable of guaranteeing quality.<\/li><li>Availability of facilities, procedures, equipment and adequate personnel.<\/li><li>Availability of <a href=\"https:\/\/productosanitario.es\/responsable-tecnico-y-prrc\/\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">a technical manager<\/a>.<\/li><li>Availability of a document archiving system (<a href=\"https:\/\/www.productosanitario.es\/expediente-tecnico-del-producto-sanitario\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">technical file<\/a> and other required documents).<\/li><li>Availability of a person responsible for the <a href=\"https:\/\/www.productosanitario.es\/sistema-de-vigilancia\" target=\"_blank\" rel=\"noopener\" data-abc=\"true\">surveillance system<\/a>, typically the company&#8217;s technical manager.<\/li><li>Availability of a procedure for applying restriction or monitoring measures.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-f7e2a5f e-flex e-con-boxed e-con e-parent\" data-id=\"f7e2a5f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-129823b elementor-widget elementor-widget-heading\" data-id=\"129823b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Blog<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f571fc2 elementor-grid-tablet-3 elementor-widget__width-inherit elementor-grid-3 elementor-grid-mobile-1 elementor-widget elementor-widget-loop-grid\" data-id=\"f571fc2\" data-element_type=\"widget\" data-e-type=\"widget\" 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data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a65ff32 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"a65ff32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-phone-alt\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M497.39 361.8l-112-48a24 24 0 0 0-28 6.9l-49.6 60.6A370.66 370.66 0 0 1 130.6 204.11l60.6-49.6a23.94 23.94 0 0 0 6.9-28l-48-112A24.16 24.16 0 0 0 122.6.61l-104 24A24 24 0 0 0 0 48c0 256.5 207.9 464 464 464a24 24 0 0 0 23.4-18.6l24-104a24.29 24.29 0 0 0-14.01-27.6z\"><\/path><\/svg>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cf19537 elementor-widget elementor-widget-heading\" data-id=\"cf19537\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">Contact<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c0174c9 elementor-widget-mobile__width-inherit elementor-widget elementor-widget-text-editor\" data-id=\"c0174c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Write to us at<br><a href=\"mailto:info@productosanitario.es\"><span style=\"text-decoration: underline; color: #ffffff;\">info@productosanitario.es<\/span><\/a> <br>voice call or Whatsapp<br><span style=\"color: #ffffff;\">+34 669 27 21 63<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-bb888e6 e-con-full e-flex e-con e-child\" data-id=\"bb888e6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b86b8c1 elementor-widget elementor-widget-heading\" data-id=\"b86b8c1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<p class=\"elementor-heading-title elementor-size-default\">or fill out our form.<\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-17df433 elementor-align-center elementor-widget elementor-widget-button\" data-id=\"17df433\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/productosanitario.es\/en\/contact\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Form<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Prior license to operate a medical device In accordance with Royal Decree 192\/2023, natural or legal persons engaged in the manufacture, manufacture to third parties, import, grouping or sterilisation of medical devices and the facilities in which such activities are carried out will require a prior operating licence granted by the AEMPS. The establishments and [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-6897","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Prior license to operate a medical device - Consultor\u00eda de producto sanitario<\/title>\n<meta name=\"description\" content=\"The prior operating licence is a process of verification and validation of facilities and infrastructures by the AEMPS\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/productosanitario.es\/en\/prior-license-to-operate-a-medical-device\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Prior license to operate a medical device - 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